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Clinical Trials/EUCTR2007-001315-31-DK
EUCTR2007-001315-31-DK
Active, not recruiting
Not Applicable

Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)

Dr. Falk Pharma GmbH0 sites110 target enrollmentOctober 14, 2009
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ConditionsCollagenous colitisMedDRA version: 13.1Level: PTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disorders
DrugsBudenofalk 3 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Collagenous colitis
Sponsor
Dr. Falk Pharma GmbH
Enrollment
110
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 14, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Patients aged \>\= 18 years,
  • •\- Histologically established diagnosis of collagenous colitis (CC) defined as:
  • •a) Thickened sub\-epithelial collagen layer \>\= 10 µm on well\-orientated sections
  • •b) Increased amount of inflammatory cells indicating chronic inflammation in the
  • •lamina propria
  • •\- History of non\-bloody, watery diarrhoea for more than 2 weeks prior screening in
  • •patients with nexly diagnosed collagenous colitis, or history of clinical relapse for
  • •more than 1 week prior screening in patients with previously established
  • •collagenous colitis
  • •\- A mean of \>\= 3 stools/day, thereof a mean of \>\= 1 watery stolls/day, during the

Exclusion Criteria

  • •\- Other significant abnormalities at colonoscopy that may have been the cause
  • •of diarrhoea, with the exception of colonic diverticulosis and polyps \< 2 cm
  • •\- Infectious cause of diarrhoea
  • •\- Untreated active celiac disease
  • •\- Clinical suspicion of drug\-induced collagenous colitis
  • •\- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
  • •\- Abnormal hepatic function (ALT or ALP \> 2\.5 x upper limit of normal ULN), liver
  • •cirrhosis, or portal hypertension
  • •\- Local intestinal infection
  • •\- Radiation therapy towards the abdominal or pelvic region

Outcomes

Primary Outcomes

Not specified

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